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U.S. Department of Health and Human Services

Class 2 Device Recall Prelude Short Sheath Introducer

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  Class 2 Device Recall Prelude Short Sheath Introducer see related information
Date Initiated by Firm April 14, 2009
Date Posted June 10, 2009
Recall Status1 Terminated 3 on February 09, 2010
Recall Number Z-1403-2009
Recall Event ID 51877
510(K)Number K082063  
Product Classification Catheter Introducer - Product Code DYB
Product Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C, Merit Medical Systems, Inc., South Jordan, Utah 84095.

To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
Code Information Lot number V681838.
Recalling Firm/
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
Manufacturer Reason
for Recall
External tubing may separate during use, allowing blood loss.
FDA Determined
Cause 2
Process control
Action All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
Quantity in Commerce 6 units
Distribution Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = MERIT MEDICAL SYSTEMS, INC.